A-M SYSTEMS
QUALITY MANUAL
ORIGINATED BY:
Robert J. Thompson
TITLE:
Quality Manager
DATE:
01-May-2019
APPROVED BY:
Arthur B. Green III
TITLE:
President and CEO
DATE:
01-May-2019
QM-1
QUALITY MANUAL
Rev 20
Revision:
05/01/19
Date:
Page:
2 of 36
Revision History
Rev.
Date
1
6/30/2006
2
8/16/06
Changes
Initial release.
Changes from BSI report # 4843532: 7.5: renumbering, missing sections,
exclusions, scope, document outline, risk management.
First Internal audit comments.
3
9/22/06
Changes from BSI pre-assessment
4
11/3/06
Changes from BSI initial-assessment = NCR’s 100168,100169
5
2/9/07
Added reference to Policies and Procedures QSP6.2.3
6
4/19/07
Added QSP-7.2 Customer Related Processes to appropriate areas in 7.5
7
5/8/07
Specifically indicated the FDA and Canadian MDR where Regulatory bodies were
mentioned
8
9/6/07
Update the quality policy per management review 8/22/07
9
12/4/07
Update the Signature page to reflect new Quality Manger Name.
10
2/24/08
DCR #200484. Update QM to more closely resemble numbering of ISO standard.
Added EU MDD references where Regulatory bodies mentioned.
11
3/18/08
DCR #200521. Add CMDR and MDD to Quality Policy statement as per BSI audit
recommendation. Added sections 6.2.3 and 6.5.
12
5/05/08
DCR #200546. Clarify wording in section 7.2.3.
13
12/01/08
DCR #200656. Modify Quality Policy to reflect new company president.
14
06/02/09
DCR #200793 adds “QSP 7.3.2” to QM-1 4.1.2 Quality System Process Interaction.
15
09/09/10
DCR #201325. Add new service-related objective to Quality Policy.
16
09/22/11
DCR #201619. Update organization chart to add CFO.
17
03/13/17
DCR #202677. Update section 1.2.3 to remove section 6 from non-applicability.
Update quality policy page to remove the phrase “highest marks” as well as the
word “any” from the last paragraph.
18
01/22/18
DCR #202908. Update QM for compliance with 2016 version of ISO 13485
standard.
19
04/05/19
DCR #203179. Update Quality Policy to include quality slogan. Add numbering
and appropriate headers to sections 4.1.1 – 4.1.7.
20
05/01/19
DCR #203201. Identify 7.5.10 Customer Property as a permissible exclusion.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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QUALITY MANUAL
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1.
Scope ............................................................................................................................................ 7
1.1.
General ............................................................................................................................................. 7
1.2.
Application ....................................................................................................................................... 7
1.2.1. General ......................................................................................................................................... 7
1.2.2. Exclusions .................................................................................................................................... 7
1.2.3. Non-applicability .......................................................................................................................... 8
2.
3.
4.
Reference Documents................................................................................................................. 8
Definitions ................................................................................................................................... 8
Quality Management System .................................................................................................. 10
4.1.1. General Processes ....................................................................................................................... 10
4.1.2
Definition of Process Management ............................................................................................ 10
4.1.3. Process Effectiveness ................................................................................................................. 10
4.1.4. Process Change........................................................................................................................... 11
4.1.5. Outsourcing of Processes............................................................................................................ 11
4.1.6. Software Application Validation ................................................................................................ 11
4.1.7. Quality System process interaction ............................................................................................ 12
4.2.
Documentation and Records ........................................................................................................ 13
4.2.1. General ....................................................................................................................................... 13
4.2.2
Quality System Document Structure .......................................................................................... 13
4.2.3
Medical Device File ................................................................................................................... 13
4.2.4
Control of Documents ................................................................................................................ 14
4.2.5
Control of Records ..................................................................................................................... 15
5.
Management Responsibility .................................................................................................... 15
5.1.
Management Commitment ........................................................................................................... 15
5.2.
Customer Focus ............................................................................................................................. 15
5.3.
Quality Policy ................................................................................................................................ 16
5.4.
Planning ......................................................................................................................................... 16
5.4.1. Quality Objectives ...................................................................................................................... 16
5.4.2. Quality Management System Planning ...................................................................................... 17
5.5.
Responsibility, Authority and Communication .......................................................................... 17
5.5.1. Responsibility and Authority ...................................................................................................... 17
5.5.2. Management Representative....................................................................................................... 17
5.5.3. Internal Communication ............................................................................................................. 18
5.6.
Management Review ..................................................................................................................... 18
5.6.1. General ....................................................................................................................................... 18
5.6.2. Review Input .............................................................................................................................. 18
5.6.3. Review Output ............................................................................................................................ 18
6.
Resource Management............................................................................................................. 19
6.1.
Provision of Resources .................................................................................................................. 19
6.2.
Human Resources .......................................................................................................................... 19
6.2.1. General ....................................................................................................................................... 19
6.2.2. Competence, Awareness, and Training ...................................................................................... 19
6.2.3. Policies and Procedures .............................................................................................................. 19
6.3.
Infrastructure ................................................................................................................................ 20
6.4.
Work Environment and Contamination Control ....................................................................... 20
6.5.
Employee Safety Program ............................................................................................................ 20
7.
Product Realization.................................................................................................................. 20
7.1.
Planning of Product Realization .................................................................................................. 20
7.2.
Customer Related Processes ......................................................................................................... 21
7.2.1. Determination of Requirements Related to the Product ............................................................. 21
7.2.2. Review of Requirements Related to the Product ........................................................................ 21
7.2.3. Communication .......................................................................................................................... 22
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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7.3.
Design and Development............................................................................................................... 22
7.3.1. General ....................................................................................................................................... 22
7.3.2. Design and Development Planning ............................................................................................ 22
7.3.3. Design and Development Inputs................................................................................................. 23
7.3.4. Design and Development Outputs .............................................................................................. 23
7.3.5. Design and Development Review .............................................................................................. 23
7.3.6. Design and Development Verification ....................................................................................... 24
7.3.7. Design and Development Validation .......................................................................................... 25
7.3.8. Design and Development Transfer ............................................................................................. 25
7.3.9. Control of Design and Development Changes ........................................................................... 25
7.3.10.
Design and Development Files .............................................................................................. 25
7.4.
Purchasing ..................................................................................................................................... 26
7.4.1. Purchasing Process ..................................................................................................................... 26
7.4.2. Purchasing Information .............................................................................................................. 26
7.4.3. Verification of Purchased Product .............................................................................................. 26
7.5.
Production and Service Provision ................................................................................................ 27
7.5.1. Control of Production and Service Provision ............................................................................. 27
7.5.2. Cleanliness of Product and Contamination Control ................................................................... 27
7.5.3. Installation activities ................................................................................................................... 27
7.5.4. Servicing activities ..................................................................................................................... 27
7.5.5. Particular requirements for sterile medical devices .................................................................... 27
7.5.6. Validation of processes for production and service provision .................................................... 27
7.5.7. Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
28
7.5.8. Identification .............................................................................................................................. 28
Supporting Procedure: Q:\QSP\QSP-7.2 Customer Related Processes.pdf .............................................. 28
7.5.9. Traceability................................................................................................................................. 29
7.5.11 Preservation of Product .................................................................................................................. 29
7.6.
Control of Monitoring and Measuring Devices .......................................................................... 30
8.
Measurement, Analysis, and Improvement ........................................................................... 30
8.1.
General ........................................................................................................................................... 30
8.2.
Monitoring and Measurement ..................................................................................................... 31
8.2.1. Feedback ..................................................................................................................................... 31
8.2.2. Complaint Handling ................................................................................................................... 31
8.2.3. Reporting to Regulatory Authorities .......................................................................................... 31
8.2.4. Internal Audit ............................................................................................................................. 32
8.2.5. Monitoring and Measurement of Processes ................................................................................ 32
8.2.6. Monitoring and Measurement of Product ................................................................................... 32
8.3.
Control of Nonconforming Product ............................................................................................. 33
8.3.1. General ....................................................................................................................................... 33
8.3.2. Actions in Response to Nonconforming Product Detected Before Delivery .............................. 33
8.3.3. Actions in Response to Nonconforming Product Detected After Delivery ................................ 33
8.3.4. Rework ....................................................................................................................................... 34
8.4.
Analysis of Data ............................................................................................................................. 34
8.5.
Improvement ................................................................................................................................. 35
8.5.1. General ....................................................................................................................................... 35
8.5.2. Corrective Action ....................................................................................................................... 35
8.5.3. Preventive Action ....................................................................................................................... 36
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
QM-1
QUALITY MANUAL
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Revision:
05/01/19
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COMPANY PROFILE
A-M SYSTEMS (A-M Systems) is located in Sequim, Washington two hours west of Seattle.
Our Pulmonary division offers respiratory supplies to hospitals, clinics and doctors. Our
Physiology division offers electronic equipment: electrodes, capillary glass and accessories
to universities, government and industry bio-medical research labs.
A-M Systems has been committed to providing our customers with the highest quality
products promptly and economically since 1976. Most of our products are kept in stock at all
times for same day shipping. The real key to A-M Systems’ success lies with an absolute
commitment to quality from every employee. From top-level management down, in all
phases of design, manufacture and customer service, everyone must be genuinely
dedicated to providing the best product possible.
A-M Systems now produces a wide variety of products, shipping to customers all over the
country and across the world. Although the product line and customer base has grown, A-M
Systems’ philosophy remains the same: Produce the best product possible for both the
patient and the operator and build in the best quality in the industry. A-M Systems’ high
standards are maintained by always striving for continuous improvement of engineering and
manufacturing techniques. This allows us to keep our costs down and helps us to maintain
very competitive pricing.
A-M Systems has developed and implemented the Quality Management System outlined in
this Quality Manual to ensure that its products, standards, and services meet or exceed the
rigorous requirements demanded by our customers. The Quality Management System is
considered by the management of A-M Systems to be an integral and essential part of all
company operations.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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QUALITY POLICY
“Our Family, Our Quality and Service, Your Solution”
A-M Systems’ strategic mission is to earn customer business by providing high quality
products at a great value and to provide prompt delivery. A-M Systems intends to fulfill this
mission by focusing on A-M Systems’ key objectives:
·
To provide competitively priced quality products.
·
To promote a friendly work environment.
·
To achieve high customer satisfaction.
·
To engage in business transactions with high quality suppliers.
·
To continually grow both domestically and internationally.
·
To offer a service program to help ensure continued compliance and performance of
A-M Systems products in post-production.
A-M Systems has developed this quality management system to comply with ISO
13485:2016, FDA Quality System Regulations (21 CFR PART 820), EU Medical Device
Directive (MDD 93/42/EEC), Canada Medical Device Regulations (SOR/98-282), and other
applicable regulatory requirements. Top management shall remain committed to complying
with requirements and maintaining the effectiveness of the quality management system by
focusing management review efforts on the continual improvement of our quality system.
Arthur B. Green III, President
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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QUALITY MANUAL
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1. Scope
1.1.
General
The Quality Manual identifies the scope of the Quality Management System maintained by
A-M Systems. The purpose is to provide the controls necessary to:
·
Achieve the highest possible quality standards for all products and services provided by A-M
Systems.
·
Determine the needs and expectations of customers and other interested parties
·
Recognize and implement all customer and statutory requirements
·
Motivate and control the human resources that affect process quality for the purpose of
identifying, reducing, and ultimately preventing all quality deficiencies
·
Establish the quality policy and objectives of A-M Systems
·
Determine the processes and responsibilities necessary to attain the quality objectives
·
Determine and provide the resources necessary to attain the quality objectives
·
Establish methods to measure the effectiveness and efficiency of each process
1.2.
Application
1.2.1.
General
A-M Systems designs, manufactures, and distributes non-invasive medical devices for
pulmonary and respiratory therapy.
1.2.2.
Exclusions
Physiology and neuroscience products and processes are to be excluded from the
requirements listed in the ISO 13485:2016 standard. These products are not for human use
and therefore should not be included in the scope of this quality manual.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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1.2.3.
Non-applicability
The following sections of the ISO 13485:2016 standard are non-applicable for A-M Systems:
·
7.5.2 Cleanliness of product and contamination control.
The majority of A-M Systems products do not require cleaning prior to use.
For these products 7.5.2 does not apply. However, A-M Systems does have
some reusable products. All products that require sterilization include
instructions for use that indicate this as per the requirement of 7.5.2. For
these products the following do not apply under 7.5.2:
§ From 7.5.2, 6.4.1a and 6.4.1b do not apply to A-M Systems
products that are intended to be cleaned and sterilized
§ 7.5.2a A-M Systems does not clean any products prior to use or
sterilization
§ 7.5.2e A-M Systems does not remove process agents.
· 7.5.3 Installation activities, A-M Systems does not install devices
· 7.5.5, 7.5.7 sterile medical devices, A-M System does not manufacture sterile devices
· 7.5.9.2, 8.2.6(paragraph 4) implantable medical devices, A-M Systems does not
manufacture active implantable medical devices or implantable medical devices
· 7.5.10 Customer Property, not applicable to A-M Systems’ quality system.
o
2. Reference Documents
·
ISO 13485:2016– Quality Management System Requirements
·
A-M SYSTEMS - Quality System Procedures, Forms and Work Instructions
·
21 CFR, Part 820 – Quality System Regulations
·
21 CFR, Part 801 – Labeling Instructions
·
A-M Systems FDA Policies and Procedures Manual
·
Canada Medical Device Regulations (SOR/98-282)
·
EU Medical Device Directive (MDD 93/42/EEC)
·
ISO 14971 - Medical devices — Application of risk management to medical devices
·
ANSI/ASQC M1-1996: American National Standard for Calibration Systems
·
ANSIASQ Z1.4-2008: American National Standard sampling procedures and tables for
inspection by attributes
3. Definitions
Medical Device: instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro
use, software, material or other similar or related article, intended by the manufacturer to be used,
alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological
process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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— providing information by means of in vitro examination of specimens derived from the human
body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but
not in others include:
—
—
—
—
disinfection substances;
aids for persons with disabilities;
devices incorporating animal and/or human tissues;
devices for in vitro fertilization or assisted reproduction technologies.
Manufacturer: natural or legal person with responsibility for design and/or manufacture of a medical
device with the intention of making the medical device available for use, under his name; whether or
not such a medical device is designed and/or manufactured by that person himself or on his behalf
by another person(s).
Distributor: natural or legal person in the supply chain who, on his own behalf, furthers the availability
of a medical device to the end user.
Importer: natural or legal person in the supply chain who is the first in a supply chain to make a
medical device, manufactured in another country or jurisdiction, available in the country or
jurisdiction where it is to be marketed.
Life-cycle: all phases in the life cycle of a medical device, from initial conception to final
decommissioning and disposal.
Medical device family: group of medical devices manufactured by or for the same organization and
having the same basic design and performance characteristics related to safety, intended use and
function.
Post-market surveillance: systematic process to collect and analyze experience gained from medical
devices that have been placed on the market.
Risk: combination of the probability of occurrence or harm and the severity of that harm.
Risk Management: the systematic application of management policies, procedures and practices to
the tasks of analyzing, evaluating, controlling and monitoring risk.
Quality: is a degree to which a set of inherent characteristics fulfills requirements. The term quality
is also defined as a totality of characteristics of an entity that bear on its ability to satisfy stated and
implied needs.
Product: is a result of an interrelated or interacting activity or process.
Complaint: written, electronic or oral communication that alleges deficiencies related to the identity,
quality, durability, reliability, usability, safety or performance of a medical device that has been
released from the organization’s control or related to a service that affects the performance of such
medical devices.
Top Management: is a person or group of people who direct and control an organization at the
highest level. (See A-M SYSTEMS’ Organization Chart QF-5.5_1).
Continual Improvement: is a recurring activity to increase the ability to fulfill requirements. The
process of establishing objectives and finding opportunities for improvement is a continual process
through the use of audit findings and audit conclusions, analysis of data, management reviews or
other means and generally leads to corrective action or preventive action.
Design history file (DHF): a compilation of records which describes the design history of a finished
device or family of devices.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Device history record (DHR): a compilation of records containing the production history of a finished
device or family of devices.
Device master record (DMR): a compilation of records containing the procedures and specifications
for a finished device or family of devices.
Labeling: Label, instructions for use, and any other information that is related to identification,
technical description, intended purpose and proper use of the medical device, but excluding shipping
documents.
Lot: one or more components, finished devices, or products that consist of a single type, model,
class, size, composition, or software version that are manufactured under essentially the same
conditions and that are intended to have uniform characteristics and quality.
Part Specifications (PS): a document that lists items necessary to make, purchase, and inspect a
part.
Product Documentation (PD): a document that lists everything necessary to make, inspect, and ship
a product.
4. Quality Management System
4.1.1.
General Processes
In order to better meet the requirements of regulatory bodies including:
· FDA Quality System Regulations as set forth in 21 CFR PART 820,
· Labeling instructions outlined in 21 CFR Part 810,
· Canadian Medical Device Regulations (SOR/98-282),
· EU Medical Device Directive (MDD 93/42/EEC),
· And other applicable regulatory bodies
A-M Systems has established documented, implemented and maintains a quality
management system in accordance with the requirements of the ISO 13485:2016 Standard.
4.1.2
4.1.3.
Definition of Process Management
A-M Systems has:
·
Identified the processes needed for the quality management system and their
application throughout the organization considering the roles undertaken by the
organization;
·
Applied a risk-based approach to the control of appropriate processes needed for
the quality management system;
·
Determined the sequence and interaction of these processes;
Process Effectiveness
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The Quality Department maintains the signed original/s
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4.1.4.
·
Determined criteria and methods needed to ensure that both the operation and
control of these processes are effective;
·
Ensured the availability of resources and information necessary to support the
operation and monitoring of these processes;
·
Monitoring, measuring and analyzing the data from these processes and
implementing any actions necessary to achieve planned results and continual
improvement.
·
Established and maintained records needed to demonstrate conformance to this
ISO 13485:2016 and with applicable regulatory requirements.
Process Change
A-M Systems has ensured that changes made to these processes shall be:
4.1.5.
·
evaluated for their impact on the quality management system;
·
evaluated for their impact on the medical devices produced under this quality
management system;
·
controlled in accordance with the requirements of the ISO 13485:2016 standard and
applicable regulatory requirements.
Outsourcing of Processes
Where A-M Systems chooses to outsource any process that may affect product conformity with
requirements, they monitor and ensure control over such processes. The controls shall be
proportionate to the risk involved and the ability of the external party to meet the requirements in
accordance with 7.4 (Purchasing). The controls shall include written quality agreements. Control of
such outsourced processes shall be identified within the quality management system and overseen
by the Quality Manager.
4.1.6.
Software Application Validation
A-M Systems shall document procedures for the validation of the application of computer software
used in the quality management system. Such software applications shall be validated prior to initial
use and, as appropriate, after changes to such software or its application.
Supporting Procedure: Q:\QSP\QSP-4.1.6 Software Application Validation
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The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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4.1.7.
Quality System process interaction
CUSTOMER
Satisfaction
Customer Requirements
Quotations, Proforma
Invoices, and Orders
QSP:7.2
Human Resources
QSP 6.2.2
Information Resources (Doc. Cntrl)
QSP’s 4.2.3, 4.2.4, 4.2.5
Measuring/Monitoring Devices
QSP 7.6
RESOURCE
MANAGEMENT
Product Design
QSP’s 7.3, 7.3.2
Production
QSP’s 6.2.2, 6.4, 7.5.3,
7.5.5, WI’s
Product
Verification
Shipping and Distribution
QSP’s 7.5.3, 7.5.4, 7.5.5
MANAGEMENT
RESPONSIBILITY
Purchasing and Receiving
QSP’s 7.4, 7.4.1, 7.5.8,
PRODUCT
REALIZATION
Planning of
Product Realization
QSP’s 7.3, 7.3.2, 8.2.4
Customer
Communication
Plant, Facility and Equipment
QM 6.3 QSP 6.4
MEASUREMENT,
ANALYSIS AND
IMPROVEMENT
Management Policies,
Planning and Commitments
QM 5.3, 5.5
QSP’s 5.4.2, 5.6
Management Review
QSP’s 5.6
CONTINUAL IMPROVEMENT
QSP’s 5.4.2, 5.6, 8.2.2, 8.2.5, 8.4,
8.5.1, 8.5.2, 8.5.3
Monitoring/Measurement of Product
QSP’s 7.4.1, 7.5.5, 8.2.4, 8.3, 8.3.1
Monitoring/Measurement of QS
QSP’s 5.6, 8.2.2
Monitoring Post-Production Feedback
QSP’s 5.6, 7.5.4, 8.2.1, 8.2.5, 7.3.2
Customer Input
QSP’s 7.2, 7.5.4, 8.2.1, 8.2.5
Feedback
QSP 8.2.1
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The Quality Department maintains the signed original/s
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4.2.
Documentation and Records
4.2.1.
General
The quality management system consists of documented statements of the quality policy,
quality objectives, the quality manual, documented procedures required by the ISO
13485:2016 Standard, documents for planning, operation and process control, industry
regulatory requirements and all required records referenced in this manual. A file containing
or identifying documents that define product specification and quality management system
requirements is maintained for each type or model of medical device.
Supporting Procedure: Q:\QSP\QSP-8.1 Regulatory Bodies.pdf
4.2.2
Quality System Document Structure
Level 1: Outlines the quality plan – This document, the Quality Manual: QM-1
Level 2: Defines who, what, and when - All Quality System Procedures: QSP’s’
Level 3: Answers how to tasks – Instructions:
·
·
·
·
·
·
External documents (DOC)
Mechanical Drawings (DRG, DRW. IGS)
General documents (GEN)
Electrical Drawings (GRB, DRG)
Assembly work instructions (WI)
General work Instructions (WI)
Level 4: Records:
·
·
·
·
·
·
·
4.2.3
Design History Files (DHF)
Device Master Record (DMR)
Product Definitions (PD)
Part Specification (PS)
Quality Forms (QF)
Work Forms (WF)
Technical Files (TF)
Medical Device File
A file is maintained for each device, and device family, which contain documentation or
evidence of conformity of the device to the ISO 13485:2016 standard and applicable
regulatory requirements. The contents of the file shall include, but is not limited to:
·
general description of the medical device, intended use/purpose, and labelling,
including any instructions for use;
·
specifications for product;
·
specifications or procedures for manufacturing, packaging, storage, handling, and
distribution;
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
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·
procedures for measuring and monitoring;
·
as appropriate, requirements for installation;
·
as appropriate, procedures for servicing.
Supporting Procedure: Q:\QSP\QSP-4.2.3 Medical Device File.pdf
4.2.4
Control of Documents
Documents required by the quality management system are controlled. Records are a
special type of document and are controlled according to the requirements given in 4.2.5,
Control of Records.
A procedure has been established that defines the controls needed to:
·
Review and approve documents for adequacy prior to issue.
·
Review and update as necessary and re-approve documents.
·
Ensure that changes and the current revision status of documents are identified.
·
Ensure that relevant versions of applicable documents are available at points of use.
·
Ensure that documents remain legible and readily identifiable.
·
Ensure that documents of external origin are identified and their distribution controlled.
·
Prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
·
Identify the period for which controlled documentation is retained as defined in the
appropriate regulations
·
Maintain obsolete documents
·
Prevent deterioration or loss of documents
Changes to documentation are reviewed and approved either by the original approving
function or another designated function which has access to pertinent background
information on which to base decisions. Changes to documentation that effect conformity to
ISO 13485 or regulatory requirements are submitted to the appropriate body.
A-M Systems shall define the period for which at least one copy of obsolete documents shall
be retained. This period shall ensure that documents to which medical devices have been
manufactured and tested are available for at least the lifetime of the medical device as
defined by the organization but not less than the retention period of any resulting record or
as specified by applicable regulatory requirements.
Supporting Procedure: Q:\QSP\QSP-4.2.4 Control of Documents.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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4.2.5
Control of Records
Records are prepared and retained according to regulatory requirements and to provide
evidence of the effective operation of the quality management system. Records remain
legible, readily identifiable and readily retrievable. A documented procedure has been
established that defines the controls needed for the identification, storage, protection,
retrieval, retention times and disposition of records. Further, the organization has
determined that no confidential health information is contained in our records and therefore
no special methods need to be documented to ensure their protection.
Supporting Procedure: Q:\QSP\QSP-4.2.5 Control of Records.pdf
5. Management Responsibility
5.1.
Management Commitment
The General Manager and/or Quality Manager has provided documented evidence of his
commitment to the development and implementation of the quality management system and
continually improving and maintaining its effectiveness by:
·
Communicating to A-M Systems through the quality management system the importance of
meeting customer as well as statutory and regulatory requirements.
·
Establishing the quality policy.
·
Continually ensuring that quality objectives are established and met.
·
Conducting periodic management reviews.
·
Maintaining regulatory requirements (licensing, new design, design changes, NCR, recall,
etc.).
·
Ensuring the availability of necessary resources.
Supporting Procedure: Q:\QSP\QSP-5.6 Management Review.pdf
5.2.
Customer Focus
The General Manager ensures customer requirements are determined and fulfilled with the
aim of enhancing customer satisfaction. This is done through any one or more of the
following:
·
Determining the requirements specified by the customer, including the requirements for
delivery.
·
Determining the requirements not stated by the customer but necessary for specified use or
known and intended use through past history, experience and/or customer needs.
·
Determining the statutory and regulatory requirements related to the product.
·
Monitoring information relating to customer perception as to whether A-M Systems has
fulfilled customer requirements, through customer satisfaction trend analysis, rejections,
performance, on-time delivery, etc.
·
Focusing on process improvement, ensuring value.
Supporting Procedure: Q:\QSP\QSP-7.2 Customer Related Processes.pdf
Supporting Forms: Q:\QF\QF-8.2_4 Customer Service Survey.doc
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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5.3.
Quality Policy
Top management has ensured that the quality policy:
·
Is appropriate to its purpose
·
Includes a commitment to comply with all requirements, both of the Standard and applicable
regulations, and to continually improve the effectiveness of the system
·
Provides a framework for establishing and reviewing quality objectives
·
Is communicated and understood within the organization
·
Is periodically reviewed for continuing suitability.
·
The company’s quality policy is documented and signed in section 1.
5.4.
Planning
5.4.1.
Quality Objectives
The General Manager ensures quality objectives, including those needed to meet
requirements for the product (product manager), are established for relevant functions
(Senior Engineer) and levels within the organization (General Manager). The quality
objectives shall be measurable and consistent with the quality policy and include the
planning of product realization (Production Manager) to include the quality objectives
(Quality Manager) and requirements for the product (Product Manager).
When objectives are being established, management may evaluate any or all of the
following:
·
Current and future needs of A-M Systems and industry
·
Relevant findings from management review meetings
·
Product and process performance
·
Levels of satisfaction, internal and external
·
Assessment results
·
Competitor analysis, bench marking, new opportunities for improvement, and
·
Continually sourcing new resources needed to fulfill quality objectives.
Objectives are systematically reviewed and revised, as necessary.
Supporting Procedure: Q:\QSP\QSP-5.6 Management Review.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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5.4.2.
Quality Management System Planning
The General Manager ensures the planning of the quality management system is carried out
in order to meet the requirements given in the quality manual section 4.1, as well as the
quality objectives, and that the integrity of the quality management system is maintained
when changes to the quality management system are planned and implemented.
Supporting Procedure: Q:\QSP\QSP-5.4.2 Quality Management System Planning.pdf
5.5.
Responsibility, Authority and Communication
5.5.1.
Responsibility and Authority
The General Manager has ensured responsibilities and authorities are defined, documented
and communicated within the organization. The General Manager has established the
interrelation of all personnel involved in any facet of quality, or whose work affects quality,
ensuring these employees have the independence and authority necessary to perform their
tasks. These relationships are outlined below and assigned in the Organization Chart.
Supporting Form: Q:\QF\QF-5.5_1 Organizational Chart.doc
5.5.2.
Management Representative
The General Manager has appointed a Quality Representative, who irrespective of other
responsibilities has responsibility and authority for:
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
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·
Ensuring that processes needed for the quality management system are established,
implemented and maintained.
·
Reporting to top management on the performance, effectiveness and any deficiencies in the
quality management system and any need for improvement.
·
Ensuring promotion of the awareness of regulatory and customer requirements throughout
the organization.
5.5.3.
Internal Communication
The General Manager ensures appropriate communication processes are established within
the organization and that communication takes place regarding the effectiveness of the
quality management system.
5.6.
Management Review
5.6.1.
General
The General Manager reviews the organization's quality management system via
management review meetings at documented planned intervals. A-M Systems meets at
least twice a year, to ensure its continuing suitability, adequacy and effectiveness. The
rationale for this frequency will be documented during each management review meeting.
This review includes assessing opportunities for improvement and the need for changes to
the quality management system, including the quality policy and policy objectives.
5.6.2.
Review Input
The input to management review includes information on:
5.6.3.
·
Customer feedback
·
Complaint Handling
·
Reporting to Regulatory Authorities
·
Results of audits, internal, supplier and third party
·
Monitoring and Measurement of Processes (Process performance and product
conformity)
·
Status of preventive and corrective action,
·
Follow-up actions from previous management reviews, and review of planned changes
that could affect the quality management system
·
Recommendations for improvement, and
·
Applicable New or revised regulatory requirements.
Review Output
The output from the management review states any decisions and actions related to:
· Improvement needed to maintain the sustainability, adequacy, and effectiveness of the
quality management system and its processes
· Improvement of product related to customer requirements
· Changes needed to respond to applicable new or revised regulatory requirements
· Resource needs
· Documentation of the justification for the frequency of management reviews
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Records of management review are maintained following 4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-5.6 Management Review.pdf
6. Resource Management
6.1.
Provision of Resources
General Manager has determined and provided the resources needed to implement and
maintain the quality management system, continually improve its effectiveness, and to
enhance customer satisfaction by meeting customer and regulatory requirements.
6.2.
Human Resources
6.2.1.
General
Personnel performing work affecting product quality shall be competent on the basis of
appropriate education, training, skills and experience.
A-M Systems has a documented procedure for establishing competence, providing needed
training, and ensuring awareness of personnel.
6.2.2.
Competence, Awareness, and Training
Top management will:
·
Determine the necessary competence for personnel performing work affecting product
quality;
·
Provide training or take other actions to satisfy these needs;
·
Evaluate the effectiveness of the actions taken. The extent of the evaluation of training
effectiveness may be proportionate to the risk associated with the work for which the training
or other action is being provided;
·
Ensure that its personnel are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives;
·
Maintain appropriate records of education, training, skills and experience following 4.2.5,
Control of Records.
Supporting Procedure: Q:\QSP\QSP-6.2.2 Competence, Awareness and Training.pdf
Supporting Procedure: Q:\QSP\QSP-6.2.3 Policies and Procedures.pdf
Supporting Form: Q:\QF\QF-6.2_10 Employee Training Effectiveness Review
6.2.3.
Policies and Procedures
A major goal of A-M Systems is to keep our employees informed of current policies and updated
information. Therefore, we have published a comprehensive statement of Policies and Procedures and
Explanation of Employee Benefits to help meet this objective. We feel that this handbook, when
understood and referenced by employees, is one way we can accomplish this goal.
Supporting Procedure: Q:\QSP\QSP-6.2.3 Policies and Procedures.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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6.3.
Infrastructure
A-M Systems has determined, provides and maintains the infrastructure needed to achieve
conformity to product requirements, prevent product mix-up and ensure orderly handling of
product. The Infrastructure includes, as appropriate:
·
Buildings, workspace and associated utilities;
·
Process equipment, both hardware and software
·
Supporting services such as transport, communication, or information systems.
Associated maintenance activities are performed and documented following QSP, 4.2.5,
Control of Records.
Supporting Form: Q:\QF\QF-7.5_3 Maintenance Schedule.doc
Supporting Form: Q:\QF\QF-7.5_7 Information Systems Maintenance Schedule.doc
6.4.
Work Environment and Contamination Control
A-M Systems has determined and manages the work environment needed to achieve
conformity to product requirements. The documented requirements for the work
environment take into account the following:
·
Processes set up in that location;
·
Level of skill required
·
Quality of environment; heat, humidity, light, and air
·
Safety factors associated with process or equipment
·
Level of supervision
·
Possible requirements for the training and supervision of temporary employees if necessary
Supporting Procedure: Q:\QSP\QSP-6.4 Work Environment and Contamination
Control.pdf
6.5.
Employee Safety Program
A-M Systems places a high value on the safety of its employees. Top management is
committed to providing a safe workplace for all employees and has developed a program for
injury prevention to involve management, supervisors, and employees in identifying and
eliminating hazards that may develop during our work process. The goal of the program is
zero injuries.
Supporting Procedure: Q:\QSP\QSP-6.5 Accident Prevention Program.pdf
7.
7.1.
Product Realization
Planning of Product Realization
The General Manager plans and develops the processes needed for product realization.
Planning or product realization is consistent with the requirement of the other processes of
the quality management system.
When planning product realization, management determines the following as appropriate:
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
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·
Quality objectives and requirements for the product.
·
The need to establish processes, documents, and provide resources specific to the product,
including infrastructure and work environment.
·
Required verification, validation, monitoring, inspection and test, handling, storage,
distribution and traceability activities specific to the product, and the criteria for product
acceptance.
·
Records needed to provide evidence that the realization processes and resulting product meet
regulatory, registration, and realization requirements.
·
The application of risk management techniques as appropriate.
The output of this planning is in a documented form suitable for A-M Systems’ method of
operation. Records are retained following QSP-4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-7.3.2 Risk Management.pdf
7.2.
Customer Related Processes
7.2.1.
Determination of Requirements Related to the Product
Management determines:
7.2.2.
·
Requirements specified by the customer, can be met.
·
Requirements not stated by the customer but necessary for specified use or known and
intended use of the final product.
·
Statutory and regulatory requirements related to the product can be met.
·
Any user training needed to ensure specified performance and safe use of the medical device.
·
Any additional requirements deemed necessary by the organization based on experience,
knowledge and history of the product.
Review of Requirements Related to the Product
All proposals and contracts are reviewed prior to the organization's commitment to supply a
product to the customer and shall ensure that:
·
Product requirements are defined, accepted and documented, including special requirements.
·
Contract or order requirements differing from those previously expressed are resolved and
accepted.
·
Applicable regulatory requirements are met.
·
Any user training identified in accordance with 7.2.1 is available or planned to be available.
·
The organization has the ability to meet the defined requirements.
Where the customer provides no documented statement of requirements, the customer
requirements are confirmed before accepting the order.
Any contract change, order amendment, specification change or delivery variations to an
existing order or contract, are to be subjected to the contract review above. Once the
change has been formally approved, the revised information is immediately communicated
to the responsible individuals.
Records of the results of the review and actions arising from the review shall be maintained
per paragraph 4.2.5, Control of Records.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Supporting Procedure: Q:\QSP\QSP-7.2 Customer Related Processes.pdf
7.2.3.
Communication
Management has selected and implemented a method for effectively communicating with
customers concerning:
·
Product information
·
Enquiries, contracts or order handling, including amendments
·
Customer feedback, including customer complaints and advisory notices.
·
Customer communication is done by authorized personnel.
Critical quality or service related communications with customers are documented and
become part of the quality records.
The organization shall communicate with regulatory authorities in accordance with applicable
regulatory requirements.
Supporting Forms: Q:\QF\QF-8.2_4 Customer Service Survey.doc
7.3.
Design and Development
7.3.1.
General
The organization shall maintain a documented procedure for design and development.
7.3.2.
Design and Development Planning
The acquisition of new process equipment and/or the development of new products,
processes, delivery methods and/or any significant change in the company’s operations are
critical opportunities for effective quality control review. The impact of changing production
dynamics on quality control must be carefully assessed and become an integral and
proactive part of the planning process. Procedure QSP-7.3, Design and Development has
been established that outlines design from the early stage to final product.
The Product Managers identify and document the planning goal(s) as well as plan and
control the design and development of product. Plans describe or reference these activities,
and define responsibility for design implementation. Planning output is updated, as
appropriate, or as the design and development progress. Qualified personnel or their
designee with adequate resources, coordinate developmental activities for each new design
project. The Product Managers determines:
·
The design and development stages
·
The review, verification and validation, and design transfer activities that are appropriate to
each design and development stage
·
The responsibilities and authorities for design and development
·
The methods to ensure traceability of design and development outputs to design and
development inputs
·
The resources needed, including necessary competence of personnel.
The Product Managers are responsible for identifying and coordinating the necessary
interface between all parties involved in, or potentially affected by the design, including
customer and regulatory authorities.
The Product Managers manage the interfaces between different groups involved in design
and development to ensure effective communication and clear assignment of responsibility.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Planning output shall be updated, as appropriate, as the design and development
progresses.
Design procedures are to be developed to provide the flow of all-pertinent design information
and changes for the purpose of regular review and/or comment.
7.3.3.
Design and Development Inputs
The functional and performance requirements of any new design, product, or process shall
be developed through analysis of past quality problems; product failures; contract review
documentation; statutory requirement; and customer or company standards. These findings
are to be documented or referenced in the design plan.
Inputs relating to product requirements are determined and records maintained per
paragraph 4.2.4, Control of Records. These shall include:
·
Functional, performance, usability and safety requirements, according to the intended use;
·
Applicable statutory and regulatory requirements;
·
Information derived from previous similar designs, where applicable;
·
Other requirements essential for design and development; and
·
Outputs of risk management.
The Product Managers shall review these inputs for adequacy and approval. Requirements
shall be complete, unambiguous, able to be verified or validated, and not in conflict with
each other.
Supporting Procedure: Q:\QSP\QSP-7.3.2 Risk Management.pdf
7.3.4.
Design and Development Outputs
The purpose of the Design Plan is to clearly identify design output requirements prior to the
commencement of any new design task. The outputs of design and development shall be
provided in a form that enables verification against the design and development input and
are approved prior to release. Records are maintained following QSP-4.2.5, Control of
Records.
Design and development outputs:
7.3.5.
·
Meet or exceed the input requirements for design and development;
·
Provide appropriate information for purchasing, production and for service provision;
·
Contain or clearly reference product acceptance criteria; and
·
Specify the characteristics of the product that are essential for its safe and proper use.
Design and Development Review
The progress of design work is reviewed in formal review meetings attended by
representatives of the department(s) ultimately responsible for the commissioning and
operation of the design. At suitable intervals, systematic reviews of design and development
shall be conducted:
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
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·
To evaluate the ability of the results of design and development to fulfill requirements; and
·
To identify problems and propose necessary actions.
Participants in such reviews shall include representatives of the functions concerned with the
design and development stages(s) being reviewed, as well as other specialist personnel,
suppliers or customers. Records of the results of the reviews and any necessary actions
shall be maintained per paragraph 4.2.5, Control of Records and include the identification of
the design under review, the participants involved and the date of the review.
7.3.6.
Design and Development Verification
Design verification is essential. Verification shall be performed to ensure that the design and
development outputs have satisfied the design and development input requirements. The
specific duties of the design verification team may include:
·
Performing alternative calculations
·
Comparing the new design with alternative designs and/or options
·
Arranging product and process tests
·
Reviewing design work-in-progress documents before release.
The organization shall document verification plans the include methods, acceptance criteria
and, as appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have an interface
with, other medical device(s), verification shall include confirmation that the design outputs
meet the design inputs when so connected or interfaced.
Records of the results of the verification and any necessary actions shall be maintained per
paragraph 4.2.5, Control of Records.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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7.3.7.
Design and Development Validation
Design and development validation shall be performed in accordance with planned
arrangements following the design and development planning, stated in paragraph 7.3.2,
Design and Development Planning, after successful design verification or as soon as
practical. The purpose of design and development validation is to ensure that the resulting
product is capable of fulfilling the requirements for the specified intended use or application.
The organization shall document validation plans that include methods, acceptance criteria
and, as appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have an interface
with, other medical device(s), validation shall include confirmation that the requirements for
the specified application or intended use have been met when so connected or interfaced.
Wherever practicable, validation shall be completed prior to the delivery or implementation of
the product. National or regional regulatory clinical evaluations and/or evaluation of
performance are conducted on the medical devices, if required. The results of such tests
are to be thoroughly documented for comparison against later results. If there are different
intended uses, multiple validations may be required.
Records of the results of validation and any necessary actions shall be maintained per
paragraph 4.2.5, Control of Records.
7.3.8.
Design and Development Transfer
The organization shall maintain a documented procedure for transfer of design and
development outputs to manufacturing. This procedure shall ensure that design and
development outputs are verified as suitable for manufacturing before becoming final
production specifications and that production capability can meet product requirements.
Records of the design transfer shall be maintained per paragraph 4.2.5, Control of Records.
7.3.9.
Control of Design and Development Changes
Design and development changes shall be identified and records maintained. The changes
shall be reviewed, verified and validated, as appropriate, and approved by the Product
Managers prior to implementation. The review of design and development changes shall
include evaluation of the effect of the changes on constituent parts, delivered product,
products in process, inputs or outputs of risk management and product realization
processes.
Records of the results of the review of changes and any necessary actions shall be
maintained per paragraph 4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-7.3 Design and Development.pdf
7.3.10. Design and Development Files
The organization shall maintain a design and development file for each medical device type
or medical device family. This file shall include or reference records generated to
demonstrate conformity to the requirements for design and development and records for
design and development changes.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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7.4.
Purchasing
7.4.1.
Purchasing Process
A process has been established to ensure that purchased items or services conform to the
specified purchase requirements. The type and extent of control applied to the supplier or
subcontractor and the purchased item or service is dependent upon the effect of the
purchased item or service on subsequent product realization or the final product.
A-M Systems evaluates and selects suppliers and subcontractors based on their ability to
supply items or services in accordance with the organization's requirements. Criteria for
selection, evaluation and re-evaluation have been established. Supplier evaluations will also
be based on the effect of the purchased product on the quality of the device and
proportionate to the risk associated with the device. Records of the results of evaluations
and any necessary actions arising from the evaluation are maintained per paragraph 4.2.5,
Control of Records.
7.4.2.
Purchasing Information
Purchasing information defines the item or service to be purchased, including where
appropriate:
·
Requirements for approval of product, procedures, processes and equipment
·
Requirements for qualification of personnel
·
Quality management system requirements
·
A written agreement or acknowledgment that the supplier notify the organization of changes
in the purchased product prior to implementation of any changes that affect the ability of the
purchased product to meet specified purchase requirements
·
Traceability requirements; Copies of relevant purchasing documents are retained, where
necessary, for purposes of traceability as defined in paragraph 7.5.9 and as per paragraph
4.2.5 Control of Records.
Purchase orders are reviewed and approved prior to transmission.
7.4.3.
Verification of Purchased Product
A-M Systems performs inspection or other activities to the extent necessary to ensure that
purchased items or services meet the specified purchase requirements.
The extent of verification activities shall be based on the supplier evaluation results and
proportionate to the risks associated with the purchased product.
When A-M Systems becomes aware of any changes to the purchased product, the
organization shall determine whether these changes affect the product realization process or
the medical device.
Where A-M Systems or its customers intend to perform verification at the supplier’s
premises, A-M Systems shall define the intended verification arrangements and method of
product release in the purchasing information. Records of verification are maintained
following QSP-4.2.5.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Supporting Procedure: Q:\QSP\QSP-7.4 Purchasing.pdf
Supporting Procedure: Q:\QSP\QSP-7.4.1 Supplier Evaluation.pdf
7.5.
Production and Service Provision
7.5.1.
Control of Production and Service Provision
A-M Systems plans and carries out production under controlled conditions. Controlled
conditions include, as applicable:
7.5.2.
·
The availability of documented information that describes the characteristics of the product.
·
The availability of any necessary documented work instructions, reference materials and
reference standards.
·
The use of suitable equipment.
·
The availability and use of monitoring and measuring devices.
·
The implementation of suitable monitoring and measurement.
·
The implementation of release and delivery activities.
·
The implementation of defined operations for labeling and packaging.
·
Lot records are maintained for each medical device to comply with requirements for
traceability. These records show the quantity manufactured and the quantity released to the
customer and are verified and approved.
Cleanliness of Product and Contamination Control
Documented procedures describe, as applicable, the method and extent of cleaning each
product undergoes prior to its shipment to the customer. Individual work instructions provide
more detailed cleaning beyond those specified in QSP-6.4 if it is of significant to its use.
Supporting Procedures: Individual Work Instructions
Supporting Procedure: Q:\QSP\QSP-6.4 Work Environment and Contamination
Control.pdf
7.5.3.
Installation activities
A-M Systems does not provide installation activities
7.5.4.
Servicing activities
Documented procedures or work instructions describe, as applicable the method and extend
for performing servicing activities. Service records are maintained through service reports
(QF-7.5_4), or customized reports.
Supporting Procedures: Individual Work Instructions
7.5.5.
Particular requirements for sterile medical devices
A-M Systems does not provide sterile devices
7.5.6.
Validation of processes for production and service provision
A-M Systems validates any process where subsequent monitoring or measurement cannot
verify the resulting output. This includes any process where deficiencies become apparent
only after the product is in use.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Validation demonstrates the ability of these processes to achieve planned results
A-M Systems establishes arrangements for such processes, including, as applicable:
·
Defined criteria for review and approval of the processes.
·
Equipment and personnel.
·
Use of specific methods and procedures.
·
Full compliance with all relevant regulatory standards and codes.
·
Maintenance of production equipment.
·
Plans for any necessary recalibrations
·
Requirements for records, paragraph 4.2.5, Control of Records.
Special processes are monitored in accordance with the above criteria, but with special
attention to ensure that all process specifications and other exceptional monitoring and
compliance requirements are fully met.
Documentation exists for the validation of computer software for production or monitoring
purposes, where such application can affect the ability of the product to conform to specified
requirements. Applications are validated prior to initial use. Records are maintained
following QSP-4.2.5, Control of Records.
Supporting Procedures: Individual Work Instructions
7.5.7. Particular Requirements for Validation of Processes for Sterilization and Sterile
Barrier Systems
A-M Systems does not provide or manufacture any sterile products
7.5.8.
Identification
As appropriate, in-process product, finished product, returned product and nonconforming
product and materials are identified by suitable means.
Identification of product status shall be maintained throughout the production, storage,
installation and servicing of product to ensure that only product that has passed the required
inspection and tests or released under an authorized concession is dispatched, used or
installed.
If required by applicable regulatory requirements, the organization will document a system to
assign unique device identification to the medical device.
The company will also maintain a procedure to ensure that medical devices returned to the
organization are identified and distinguished from conforming product.
Supporting Procedure: Q:\QSP\QSP-7.2 Customer Related Processes.pdf
Supporting Procedure: Q:\QSP\QSP-7.5.8 Identification and Traceability.pdf
Supporting Procedure: Q:\QSP\QSP-8.3 Control of Nonconforming Product.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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7.5.9.
Traceability
As appropriate, in-process product, finished product, returned product and nonconforming
product and materials are identified by suitable means and records are maintained per
paragraph 4.2.5, Control of Records.
7.5.9.1
General
Where applicable, the extent and thoroughness of the method of traceability is agreed upon
between the customer and A-M Systems, with documented details approved by both parties,
before work commences. Maintained records include the name and address of the shipping
package consignee. Records shall contain sufficient information to permit complete and
rapid withdrawal of the medical device from the market.
Product status, with respect to monitoring and measurement requirements, is maintained
throughout production ensuring that only conforming product is released, unless authorized
by concession, to the customer.
Supporting Procedure: Q:\QSP\QSP-7.5.8 Identification and Traceability.pdf
7.5.11 Preservation of Product
A-M Systems preserves the conformity of product during internal processing and delivery to
the intended destination according to documented procedures. These procedures address
limited shelf life, identification, handling, packaging, storage and protection as applicable.
Preservation shall also apply to the constituent parts of a product. The exact criteria for
handling, storing, packaging, preserving and delivery of each product are defined in the
relevant process documentation.
Special conditions are recorded as required and follow QSP-4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-7.5.11 Preservation of Product.pdf
Supporting Procedure: Q:\QSP\QSP-7.2 Customer Related Processes.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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7.6.
Control of Monitoring and Measuring Devices
A-M Systems determines the monitoring and measurement to be undertaken and the
monitoring and measuring devices needed, to provide evidence of conformity of product to
determined requirements following paragraph 7.2.1, Determination of Requirements Related
to the Product.
A-M Systems has established a documented procedure to ensure that monitoring and
measurement is carried out in a manner that is consistent with the monitoring and
measurement requirements.
Where necessary to ensure valid results, measuring equipment is:
·
Calibrated or verified at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards. Where no such standards exist,
the basis used for calibration or verification shall be recorded
·
Adjusted or re-adjusted as necessary
·
Identified to enable the calibration status to be determined
·
Safeguarded from adjustments that would invalidate the measurement result
·
Protected from damage and deterioration during handling, maintenance and storage
In addition the validity of previous measurement results is assessed and recorded when the
equipment is found not to conform to requirements. Appropriate action is then taken on the
equipment and any product affected. Records of the results of calibration and verification
shall be maintained per paragraph 4.2.5, Control of Records.
Computer software, when used in the monitoring and measurement of specified
requirements, will be assessed for its ability to satisfy the intended application. This shall be
undertaken prior to initial use and reconfirmed as necessary.
Supporting Procedure: Q:\QSP\QSP-7.6 Control of Monitoring and Measuring
Devices.pdf
8. Measurement, Analysis, and Improvement
8.1.
General
A-M Systems plans and implements the monitoring, measurement, analysis and
improvement processes needed to:
·
demonstrate conformity of the product
·
ensure conformity of the quality management system
·
maintain the effectiveness of the quality management system
·
continually improve the effectiveness of the quality management system
This includes determination of applicable methods, including statistical techniques,
especially where the use of such techniques is a regulatory requirement.
Records are maintained per paragraph 4.2.5, Control of Records.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Supporting Procedure: Q:\QSP\QSP-5.6 Management Review.pdf
Supporting Procedure: Q:\QSP\QSP-8.2.2 Internal Quality Audits.pdf
8.2.
Monitoring and Measurement
8.2.1.
Feedback
Customer supplied information is continually monitored to see if their requirements are being
met. A documented feedback system provides early warning of quality problems and input
for possible corrective or preventive action.
A-M Systems maintains a documented procedure for the feedback process. The feedback
process shall include provisions to gather data from production as well as post-production
activities.
Information gathered in the feedback process shall server as potential input into risk
management for monitoring and maintaining the product requirements as well as the product
realization or improvement process.
Supporting Procedure: Q:\QSP\ QSP-8.2.1 Customer Feedback and Post Market
Surveillance.pdf
Supporting Forms: Q:\QF\QF-8.2_4 Customer Service Survey.pdf
8.2.2.
Complaint Handling
A-M Systems maintains documented procedures for timely complaint handling in accordance
with applicable regulatory requirements.
These procedures include at a minimum requirements and responsibilities for:
·
Receiving and Recording Information
·
Evaluating information to determine if the feedback constitutes a complaint
·
Investigating complaints
·
Determining the need to report the information to the appropriate regulatory
authorities
·
Handling of complaint-related product
·
Determining the need to initiate corrections or corrective actions
If any complaint is not investigated, justification shall be documented. Any correction or
corrective action resulting from the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the complaint,
relevant information shall be exchanged between the organization and the external party
involved.
Complaint handling records shall be maintained as per paragraph 4.2.5, Control of Records.
8.2.3.
Reporting to Regulatory Authorities
The organization maintains a documented procedure for providing applicable regulatory
authorities with notifications of complaints where such complaints meet specified reporting
criteria or adverse events or issuance of advisory notices.
Regulatory reporting records will be maintained as per paragraph 4.2.5, Control of Records.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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8.2.4.
Internal Audit
A-M Systems conducts internal audits at planned intervals to determine whether the quality
management system conforms to:
·
Appropriate regulatory requirements including 21 CFR part 820 and 801
·
The planned arrangements following paragraph 7.1, Planning of Product Realization
·
The requirements of the ISO 13485:2016(E) International Standard
·
The quality management system requirements established by the organization and,
·
Is effectively implemented and maintained.
Internal audits are necessary to verify the implementation and measure the effectiveness of
A-M Systems’ total quality performance. Top management is responsible for the selection
and training of the Auditor(s). Auditors shall not audit their own areas of responsibility.
Each element of the quality system is audited regularly; a minimum of once per year, in
accordance with documented procedures. Depending on the criticality of the activity/area to
be audited and the results of previous audits this frequency may be increased. The audit
criteria, scope, frequency and methods are defined.
The results of each audit are documented and distributed to top management, and those
persons responsible for the activities/areas that have been audited. When an audit report
identifies significant quality failures and/or recommends immediate remedial action, the
person responsible for the audited activity/area is to plan and initiate corrective action in a
timely manner.
Follow-up audits, include the verification of the actions taken and the reporting of verification
results follow paragraph 8.5.2, Corrective Action, and serve to confirm that all necessary
corrective actions have been taken.
The person responsible for the area/activity that has been audited shall ensure that actions
are taken, without undue delay, to eliminate detected nonconformities and their causes.
The responsibilities and requirements for reporting results and maintaining records follow
paragraph 4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-8.2.2 Internal Quality Audits.pdf
8.2.5.
Monitoring and Measurement of Processes
The organization applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes. These methods demonstrate
the ability of the processes to achieve planned results. Correction and preventative action
shall be taken as appropriate, when planned results are not achieved, to ensure conformity
of the product.
Records of such activities are documented and maintained per paragraph 4.2.5, Control of
Records.
Supporting Procedure: Q:\QSP\QSP-8.5.2 Corrective Action.pdf
8.2.6.
Monitoring and Measurement of Product
A-M Systems monitors and measures the characteristics of the product to verify that
requirements are fulfilled and have been met. This is carried out at appropriate stages of the
product realization process in accordance with planned arrangements following section 7.1,
Planning of Product Realization and documented procedures or instructions outlined in
section 7.5.
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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Inspection and Test Records:
·
Product release and service delivery shall not proceed until all the planned arrangements
following section 7.1, Planning of Product Realization have been satisfactorily completed,
unless otherwise approved by a relevant authority, and where applicable by the customer.
·
Evidence of conformity with the acceptance criteria shall be maintained.
·
Records shall indicate the person(s) performing any inspection or testing and those
authorizing release of the product.
·
As appropriate, records shall identify the test equipment used to perform measurement
activities.
Supporting Procedure: Q:\QSP\QSP-8.2.6 Monitoring and Measurement of Product.pdf
8.3.
Control of Nonconforming Product
8.3.1.
General
A-M Systems ensures that product and materials or components, which do not conform to
product requirements, are identified and controlled to prevent their unintended use or
delivery to a customer. The responsibility and controls for identifying nonconforming items,
and the authority to order their disposition, are contained in QSP-8.3, Control of
Nonconforming Product. Where nonconforming product is sourced from a subcontractor,
then its disposition and/or rework, and any further corrective action shall be mutually agreed
between A-M Systems’ authorized representative and the subcontractor.
The evaluation of nonconformity shall include a determination of the need for an
investigation and notification of any external party responsible for the nonconformity.
Records of the nature of the nonconformities and any subsequent action taken, including the
evaluation, and any investigation and rationale for decisions shall be maintained as per
paragraph 4.2.5, Control of Records.
8.3.2.
Actions in Response to Nonconforming Product Detected Before Delivery
A-M Systems shall deal with nonconforming product by one of the following ways:
·
Taking action to eliminate the detected nonconformity;
·
Taking action to preclude its original intended use or application;
·
Authorizing its use, release or acceptance under concession;
When nonconforming product is accepted by concession, justification must be provided,
approval must be gained, and applicable regulatory requirements must be met. Records of
the acceptance by concession and the identity of the person authorizing the concession shall
be maintained as per paragraph 4.2.5, Control of Records.
8.3.3.
Actions in Response to Nonconforming Product Detected After Delivery
When nonconforming product is detected after delivery or use has started, A-M Systems
shall take action appropriate to the effects, or potential effects, of the nonconformity.
Records of these actions are maintained as per paragraph 4.2.5, Control of Records.
The company maintains a procedure for guidance on issuing advisory notices in accordance
with applicable regulatory requirements. This procedure is capable of being put into effect at
any time as certain regulatory authorities require reporting to be done as per their published
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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timelines. Records relating to the issuance of advisory notices are maintained as per
paragraph 4.2.5, Control of Records.
8.3.4.
Rework
The company performs rework in accordance with documented procedures that takes into
account the potential adverse effect of the rework on the product. These procedures shall
undergo the same review and approval as the original procedure.
When rework is completed, the reworked product shall be verified to ensure that it meets
applicable acceptance criteria and regulatory requirements.
Records of rework shall be maintained as per paragraph 4.2.5, Control of Records.
Supporting Procedure: Q:\QSP\QSP-8.3 Control of Nonconforming Product.pdf
Supporting Procedure: Q:\QSP\QSP-8.1 Regulatory Bodies.pdf
8.4.
Analysis of Data
A-M Systems identifies, collects and analyses appropriate data to demonstrate the suitability
and effectiveness of the quality management system, and to evaluate where improvement of
the quality management system can be made. The procedures shall include determination
of appropriate methods, including statistical techniques and the extent of their use.
The analysis of data provides, at a minimum, information relating to:
·
Feedback;
·
Customer satisfaction;
·
Conformity to product requirements;
·
Characteristics and trends of processes and products, including opportunities for
improvement and preventive actions;
·
Supplier performance and suitability;
·
Audits;
·
Service reports, as appropriate;
If the analysis of data shows that the quality management system is not suitable, adequate
or effective, the analysis shall be used as input for improvement as per paragraph 8.5,
Improvement.
Supporting Procedure: Q:\QSP\QSP-8.4 Analysis of Data.pdf
Supporting Forms: Q:\QF\QF-8.2_4 Customer Service Survey.doc
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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8.5.
Improvement
8.5.1.
General
A-M Systems identifies and implements any changes necessary to ensure and maintain the
continued suitability and effectiveness of the quality management system through the use of
the quality policy, quality objectives, audit results, analysis of data, corrective and preventive
actions and management review.
A procedure has been established for assisting our customers with necessary information
should they need to issue an Advisory Notice.
Customer complaints are recorded and, as necessary, subjected to corrective and
preventive action processes, and if this is determined not to be required, the justification and
authorization shall be recorded and maintained.
Supporting Form: Q:\QSP\QSP-8.5.1 Continual Improvement.pdf
8.5.2.
Corrective Action
A-M Systems takes action, when necessary, to eliminate the cause of nonconformities in
order to prevent recurrence. Corrective actions shall be appropriate to the effects of the
nonconformities encountered and shall be taken without undue delay. Corrective actions
shall be proportionate to the effects of the nonconformities encountered.
The Quality System Procedure, QSP-8.5.2, describes the method for corrective action as
follows:
·
Review of nonconformities including complaints;
·
Determination of the causes of nonconformities;
·
Evaluation of the need for action to ensure that nonconformities do not recur;
·
Selection and implementation of appropriate steps to eliminate the cause(s) of
nonconformities;
·
Record results of investigations and actions taken;
·
Verifying that the corrective action does not adversely affect the ability to meet applicable
regulatory requirements or the safety and performance of the medical device;
·
Review and monitor the effectiveness of any corrective action(s) that are taken.
Records with results of action taken are maintained per paragraph 4.2.5, Control of Records.
Supporting Form: Q:\QSP\QSP-8.2.2 Customer Complaints.pdf
Supporting Form: Q:\QSP\ QSP-8.3.1 Advisory Notices, Recalls, and Vigilance.pdf
Supporting Procedure: Q:\QSP\QSP-8.5.2 Corrective Action.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.
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8.5.3.
Preventive Action
A-M Systems takes action, as appropriate, to eliminate the causes of potential
nonconformities in order to prevent their future occurrence. Preventive actions are
appropriate to the probable effects of the potential nonconformities.
The Quality System Procedure, QSP-8.5.3, describes the method for preventive action as
follows:
·
Determine the potential for a nonconformity and its possible cause;
·
Evaluate the need for action;
·
Plan and implement specific preventive actions as determined necessary;
·
Record the results of any investigations and actions taken;.
·
Verifying that the corrective action does not adversely affect the ability to meet applicable
regulatory requirements or the safety and performance of the medical device;
·
Monitor and review any preventive action taken and its effectiveness;
Records of the preventive action are maintained per paragraph 4.2.5, Control
Of Records
Supporting Form: Q:\QSP\QSP-8.2.2 Customer Complaints.pdf
Supporting Form: Q:\QSP\ QSP-8.3.1 Advisory Notices, Recalls, and Vigilance.pdf
Supporting Procedure: Q:\QSP\QSP-8.5.3 Preventive Action.pdf
Printed copies of this document are considered UNCONTROLLED/Reference only copies.
The Quality Department maintains the signed original/s
All printed copies must be checked against the controlled copy to verify current issue before use.